Obesity and Obesity-related Medical Conditions
Conditions
Brief summary
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.
Interventions
PROCEDUREBariatric endoscopic antral myotomy
A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haemostasis is confirmed.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND * failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination
Exclusion criteria
* Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery) * Gastroparesis * Active smoking * An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment * Previous pyloromyotomy or pyloroplasty * Gastrointestinal obstruction * Use of any medication that may interfere with weight loss or gastric emptying * Severe coagulopathy * Esophageal or gastric varices and/or portal hypertensive gastropathy * Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.) * Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease) * Malignancy * Pregnant or breast feeding * Patients not fit for general anesthesia * ASA grade IV or V * Mental or psychiatric disorder; Drug or alcohol addiction * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | baseline, 1,3,6,12 months | Weight change compared to baseline |
| Adverse events | within 30 days of procedure | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | baseline, 1,3,6,12 months | Blood pressure and anti-hypertensive medication use compared to baseline |
| Lipid profile | baseline, 1,3,6,12 months | Lipid profile compared to baseline |
| Pain scale after procedure | 3 days | measured by visual analogue scale (0:no pain - 10:worst pain) |
| Change in Quality of Life | baseline, 1,6,12 months | measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best) |
| Gastric emptying symptoms | baseline, 1,6,12 months | measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst) |
| Fasting glucose level | baseline, 1,3,6,12 months | levels compared to baseline |
| Technical success rate | 1 day | successful completion of endoscopic procedures |
| HbA1c level | baseline, 1,3,6,12 months | levels compared to baseline |
| serum liver parameters | baseline, 1,3,6,12 months | AST, ALT, ALP and GGT level compared to baseline |
| hepatic steatosis index | baseline, 1,3,6,12 months | level compared to baseline |
| NAFLD fibrosis | baseline, 1,3,6,12 months | NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis) |
| obstructive sleep apnea | baseline, 1,3,6,12 months | Change in sleep quality |
| Insulin level | baseline, 1,3,6,12 months | levels compared to baseline |
| Serum ghrelin levels | baseline, 1,3,6,12 months | Serum ghrelin levels compared to baseline |
Countries
Hong Kong
Contacts
Primary ContactStephen Ng, FRCSEd(Gen)
Outcome results
None listed